Regulatory Affairs Surveillance Specialist

Regulatory Affairs Surveillance Specialist

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

The Regulatory Affairs Surveillance Specialist will determine and execute actions necessary BLA Licenses supplements and other regulatory submissions to ensure that Grifols Plasma Operations is in compliance with organizations similar to or including the US Food and Drug Administration (FDA), Clinical Laboratory Improvement Amendments (CLIA), Plasma Protein Therapeutics Association (PPTA), Commission on Laboratory Accreditation (COLA), Health Canada, and state/province and Rest of World (ROW) and other regulatory requirements, and that to meet business objectives are met. This may include licensing activities associated with plasma collection facilities, warehouse, laboratory, medical devices and any related projects for acquisitions, new product development, additions, closures or relocations, etc. May serve as a reviewer for federal submissions and may compile documents for final submission.

Primary Responsibilities:

• Compile and process regulatory submissions through coordination with other departments and research of internal documentation including: completing applications and forms; composing cover letters and summaries; assembling, formatting and packaging submissions in a manner to facilitate the review process; submitting and tracking submissions and providing updates on status; filing, archiving and distributing submissions electronically and in hardcopy.
• Research internal document, complete applications and forms, prepare cover letters and summaries; assemble and format applications in a manner to facilitate the review process.
• Perform regulatory surveillance related to licensing activities, Source Plasma collection and medical device regulations.
• Maintain up-to-date knowledge of regulatory requirements and changes in the regulatory landscape.
• Communicate with U.S. and international agencies regarding regulatory requirements, obtain clarification and discuss and determine strategies for regulatory reporting. Filing as needed or required based upon projects/initiatives.
• Identify and analyze compliance issues that impact regulatory compliance with the ability to propose solutions or escalate to upper management.
• Review, monitor and coordinate regulatory meetings to review surveillance findings related to licensing activities, Source Plasma collection and medical devices regulations that has direct impact to the business.
• Ensure management is aware on the status of submissions/applications.
• Provide regulatory assessment on change controls for proposed changes.
• Develop internal procedures and tools and conducts informational or training sessions for stakeholders.
• May prepare and submit regulatory licensing applications to federal (U.S., Canada and ROW), state/province, local, and other regulatory authorities, as well as industry affiliates, through coordination with other departments.
• Assist in preparing responses to regulatory agency inquiries.
• Record and maintain details of all interactions with all agencies through contact reports.
• Educate and inform internal customers which may include corporate office and plasmapheresis centers regarding regulatory requirements using current regulatory citations, facts and figures to support positions.
• Proofread, review and compile documents for Authorized Official signature for final submission to federal regulatory agencies.
• Participate in company projects, may serve as department representative.
• Responsible for ad hoc regulatory reporting (i.e. vaccine adverse events).
• Maintain applicable shared mailboxes, dashboards and accounts related to licensing activities.
• Perform other duties as required.

Additional Responsibilities:

• Represent department on cross-functional project teams, as required.
• Serve as team lead for departmental projects and activities, as required.
• Must be able to perform Regulatory Affairs Specialist role.
• May review submissions/ applications compiled by the Regulatory Affairs Specialists.
• Exhibit professional behavior with internal/external business associates, reflecting positively on the company.
• Understand the quality consequences of improper job performance and is aware of potential compliance defects in their area of responsibility.
• Excellent attention to detail and accuracy required.
• Responsible for preparing presentations.
• Interface with various levels and groups throughout the organization.
• Manage multiple tasks with competing demands and deadlines.
• Participate in department related projects, goals and/or objectives.

Knowledge, Skills, and Abilities:

• Knowledge of applicable laws and regulations. Understanding of the regulatory requirements for licensing applications and reporting.
• Ability to work independently and initiate contacts essential to submission preparation.
• Ability to manage multiple and possibly conflicting priorities.
• Ability to work collaboratively as part of the regulatory team to meet group objectives.
• Ability to review a document in detail to ensure accuracy based on regulatory requirements, and to ensure the use of the appropriate forms, format, content, and authorized signatures.
• Ability to clearly communicate verbally and in writing and through professional conduct to achieve departmental objectives.
• Ability to successfully interact with regulatory agencies through professional, articulate, and courteous conversations and clear, concise written communications to establish meaningful relationships.
• Ability to effectively use Microsoft Office (particularly Word and Excel) and Adobe PDF to create, edit, and format documents.
• Ability to work with other computer systems for filing and tracking supplements and reports.
• Ability to meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives.
• Strong organizational skills with the ability to manage multiple tasks and prioritize effectively in a deadline driven environment.
• Ability to plan ahead and foresee or handle possible barriers that may appear due to a project or in the day-to-day job.
• Ability to elevate potential concerns/discrepancies to supervisors or management in a timely fashion.
• Take initiative; look for opportunities to act and contribute to the team's success.
• Ability to offer support by partnering with coworkers to promote an open, organized and challenging environment.
• Ability to work independently with limited supervision and interact well in a team environment to complete duties as required.
• Ability to think through problems clearly and logically.
• Model and demonstrate high standards of integrity, trust, openness, and respect for others.
• Ability to demonstrate openness to constructive feedback in order to improve on a continuous basis.
• Make good use of unsupervised time.
• Ability to connect individual responsibilities with company mission and department goals to meet business objectives while being a good representative of the company.
• Embrace change and continuous improvement.

Education and Experience: Typically requires 5 years of related experience with a Bachelor's degree

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups.